Pain after out-of-hospital cardiac arrest and resuscitation
Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAIN CARE Substudy of the STEPCARE Trial
This study will see if how pain is measured and treated in adults brought back after out-of-hospital cardiac arrest relates to delirium, ICU resource use, and longer-term recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 3 sites (Halmstad and 2 other locations) |
| Trial ID | NCT07564778 on ClinicalTrials.gov |
What this trial studies
PAINCARE is an observational substudy embedded within the international STEPCARE trial that collects detailed data on pain intensity, pain assessments, and analgesic use in adult patients resuscitated after out-of-hospital cardiac arrest and treated in the ICU. The study follows patients from early post-return-of-spontaneous-circulation care in the ICU and links pain and analgesic data with sedation, delirium, ICU resource use, early neurological recovery, and patient-reported long-term outcomes. No experimental interventions are given; data are collected prospectively across participating centers in Sweden. The goal is to map current pain management practices in this population and explore associations between pain care and short- and long-term outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) who suffered an out-of-hospital cardiac arrest, achieved return of spontaneous circulation within the enrollment window, remain comatose on ICU admission, and are treated at a participating center are the intended participants.
Not a fit: Patients who are awake/able to follow commands, those with traumatic or hemorrhagic causes of arrest, those already on ECMO, pregnant patients, or those with limitations of care are unlikely to be eligible or to benefit from this observational substudy.
Why it matters
Potential benefit: If successful, the findings could improve recognition and treatment of pain after cardiac arrest and help reduce delirium and improve functional recovery and quality of life.
How similar studies have performed: There is prior ICU literature linking pain and outcomes and some data on analgesia and delirium, but focused, prospective pain research specifically in post-cardiac arrest patients is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Out-of-hospital Cardiac Arrest * Adult(≥18years) * Spontaneous circulation without chest compressions ≥20 min * Comatose(Does not obey commands) * Enrolled within 4h after ROSC Exclusion Criteria: * Restrictions or limitations of care * On ECMO prior to randomization * Pregnancy * Previously randomized in the STEPCARE trial * Trauma or hemhorrage as presumed cause of arrest * Suspected or confirmed intracranial hemhorrage
Where this trial is running
Halmstad and 2 other locations
- Dep. of Intensive Care Halmstad Lasarett — Halmstad, Sweden (Recruiting)
- Department of Intensive Care, Skåne University Hospital — Malmö, Sweden (Recruiting)
- Dep. of Intensive Care, Norrlands Universitets Sjukhus — Umeå, Sweden (Recruiting)
Study contacts
- Study coordinator: Joachim P Düring, MD, PhD
- Email: joachim.during@med.lu.se
- Phone: +46705917599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.